Cold room temperature excursion checklist
Short answer: when a cold room goes above its limit, record the evidence first, hold affected product, follow the corrective action in your own HACCP plan or SOP, and let your QA lead decide what happens to the product. This checklist sorts severity against your limit and builds the incident record — it never declares product safe.
What to do now
- Note the time, readings and who discovered the incident before anything is moved.
- Segregate and label affected product as ON HOLD; do not release, ship or relabel it until your QA/HACCP lead decides.
- Follow the corrective action written in your own HACCP plan or SOP for this control point.
- Call a qualified refrigeration technician; do not attempt refrigerant, electrical or pressure-system work yourself.
Incident record to complete
- Room/asset ID, product, lot numbers and quantities affected
- Upper limit 5 °C; maximum observed 8 °C (3 °C above)
- Time above limit: 45 min (logger record attached)
- Suspected cause and evidence (alarm log, service report, door/power records)
- Disposition decided by QA/HACCP lead, with name, date and justification
- Corrective and preventive action, owner and due date
Recurring faults? Define the fix before buying
If this is not the first excursion, a repair may not be enough. Describe the room in a free project brief: the ColdMatch team reviews it, contacts suitable refrigeration suppliers on your behalf and presents organised responses you can compare.
Read: diagnosing temperature fluctuationsHow the severity is set
Within: the maximum reading did not exceed your limit. Minor: no more than 2 °C over for 30 minutes or less, with a logger record. Significant: more than 2 °C over for longer than 2 hours. Everything else is a hold-and-assess excursion, and every pharmaceutical excursion goes straight to the Responsible Person. These bands are a documentation aid chosen by ColdMatch; your HACCP plan, product specification or GDP procedure always takes precedence.
Sources for the principle of critical limits, monitoring and corrective action: Codex Alimentarius General Principles of Food Hygiene (CXC 1-1969, revised 2022) and the US FDA Food Code 2022. For pharmaceuticals, EU Good Distribution Practice guidelines (2013/C 343/01).
First-pass planning estimate using steady-state formulas and the inputs you enter. It is not an engineering design, certification or supplier quotation; a qualified refrigeration engineer must confirm the design basis. Example inputs are placeholders, not benchmarks. Not a food-safety, medical or product-release decision.